BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 6688960 · Received July 6, 2017

    Report

    Report Number
    3004209178-2017-14289
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 22, 2017
    Report Date
    July 24, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287731
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# V161124, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS RECENTLY REPLACED. THE PATIENT REPORTED IT WAS REPLACED DUE TO NORMAL BATTERY DEPLETION, AND STATED IT WAS DYING BUT DURING THE REPLACEMENT SURGERY, THEY FOUND OUT THAT THE ELECTRODES WERE "TERRIBLY BENT" SO A WHOLE NEW SYSTEM WAS PUT IN. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS IMPLANTED FOR URINARY DYSFUNCTION/SACRAL NERVE STIM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. HEALTH CARE PROFESSIONAL REPORTED THE REMOVAL OF THE ELECTRODE FROM THE BATTERY REVEALED A BROKEN ELECTRODE. IT WOULD NOT FEED PROPERLY INTO THE NEW BATTERY. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471667 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023 00613994287731

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention